Syndol Plus Tablet
Paracetamol + Tramadol Hydrochloride
325 mg + 37.5 mg
Healthcare Pharmaceuticals Ltd.
| Pack size | 30's pack |
|---|---|
| Unite Price | 8.00 BDT |
Indications
Syndol Plus Tablet is used for:
Moderate to severe pain
Adult Dose
Oral
Moderate to severe pain
Adult: 1-2 tab 6 hrly.
Max: 8 tab/day. Max duration: 5 days.
Hepatic impairment: Moderate: Increase dosing interval. Severe: Contraindicated.
Child Dose
Not recommended in child under 18 years of age.
Renal Dose
Renal impairment:
CrCl (ml/min) Dosage Recommendation
10-30 Increase dosing interva to 12 hr.ly
<10 Not recommended.
Administration
May with or without food.
Contra Indications
Hypersensitivity to tramadol, paracetamol or opioids. Situations where opioid use may be contra-indicated (e.g. acute intoxication with alcohol, hypnotic drugs, centrally-acting analgesics, opioids or psychotropic drugs). Severe hepatic impairment, uncontrolled epilepsy. Concurrent use or within 2 wk of discontinuation from MAOIs.
Precautions
Patient w/ epilepsy controlled by treatment, risk of seizure, cranial trauma, biliary tract disorder, altered state of consciousness for unknown reasons, problems affecting the resp centre or resp function, increased intracranial pressure, suicidal tendency or patients in a state of shock. Not a suitable substitute in opioid-dependent patients. May cause withdrawal symptoms, dependence and abuse. Severe renal impairment. Elderly. Pregnancy and lactation. Patient Counselling May impair ability to drive or operate machinery. Monitoring Parameters Monitor pain relief, resp rate, BP, and pulse rate; signs of tolerance, abuse, or suicidal ideation.
Pregnancy-Lactation
Pregnancy
Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome; available data in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage
Labor and delivery
Use of tramadol during labor may lead to respiratory depression in the neonate
Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates; an opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate; use is not recommended in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate; opioid analgesics, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions; however, this effect is not consistent and may be offset by increased rate of cervical dilation, which tends to shorten labor; monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression
Lactation
Tramadol and its active metabolite, O-desmethyltramadol (M1), are present in human milk; there are published studies and cases that have reported excessive sedation, respiratory depression, and death in infants exposed to M1 via breast milk; women who are ultra-rapid metabolizers of tramadol achieve higher than expected serum levels of opioids, potentially leading to higher levels of M1 in breast milk that can be dangerous in their breastfed infants; in women with normal tramadol metabolism (normal CYP2D6 activity), the amount of tramadol secreted into human milk is low and dose-dependent
Interactions
Increased risk of seizures and serotonin syndrome w/ SSRIs, SNRIs, TCAs, and 5-HT agonists (e.g. sumatriptan). Increased CNS depression w/ barbiturates, benzodiazepines, other anxiolytics, hypnotics, sedative antidepressants, sedative antihistamines, neuroleptics, centrally-acting antihypertensive drugs, thalidomide and baclofen. Decreased analgesic efficacy w/ ondansetron. Increased INR w/ warfarin.
Potentially Fatal: Increased risk of seizure and serotonin sydrome w/ MAOIs.
Side Effects
Side effects of Paracetamol + Tramadol Hydrochloride :
Postural hypotension, resp depression, hepatotoxicity, Stevens-Johnson syndrome, toxic epidermal necrolysis, bradycardia, collapse, allergic reactions w/ resp symptoms (e.g. dyspnoea, bronchospasm, wheezing, angioneurotic oedema), changes in appetite, motor weakness, changes in mood, activity, cognitive and sensorial capacity; exacerbation of asthma, withdrawal symptoms (e.g. agitation, anxiety), skin rash, blood dyscrasias, hypoprothrombinemia.
Potentially Fatal: Severe anaphylactic reactions.
Mode of Action
Tramadol is a centrally acting opioid analgesic which binds to mu-opioid receptors and weakly inhibits the reuptake of norepinephrine and serotonin. Paracetamol, a para-aminophenol derivative, has analgesic, antipyretic and weak anti-inflammatory activity. Together, tramadol and paracetamol has faster onset of action compared to tramadol alone and longer duration of action compared to paracetamol alone.
Note
Syndol Plus 325 mg + 37.5 mg Tablet generic name is Paracetamol + Tramadol Hydrochloride. Syndol Plus 325 mg + 37.5 mg Tablet is manufactured by Healthcare Pharmaceuticals Ltd.Syndol Plus is availble in all over Bangladesh.
Mes BD drug index information on Syndol Plus Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.